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NCT00449774
Bioequivalence And Effect Of Food And Water On Lamotrigine in Healthy Volunteers
Phase 1 trial testing Lamotrigine IR tablets in Mental Disorders in 220 participants. Completed in 19 June 2007.
19 June 2007
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 220 |
| Start date | 7 May 2007 |
| Primary completion | 19 June 2007 |
| Estimated completion | 19 June 2007 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Lamotrigine IR tablets — full drug profile →
- Lamotrigine ODT tablets — full drug profile →
Conditions studied
- Mental Disorders — all drugs for Mental Disorders →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 19 to 55, any sex, with Mental Disorders. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study intends to demonstrate bioequivalence of two formulations, the effect of food and water on one formulation and safety and tolerability of two formulations of lamotrigine in healthy male and female volunteers
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT00449774
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other GlaxoSmithKline trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00449774 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 8 August 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00449774.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing